Merck Ebola Vaccine Approved in Europe
The European Commission granted marketing authorization to Ervebo, a Merck vaccine, on November 11th. This was following the approval by the European Medicines Agency to have it licensed. The vaccine is currently being used under the category of “compassionate use” which is comparable to a clinical trial. Merck will work with the Food and Drug Administration (FDA) and regulatory agencies in a number of countries in Africa to license the vaccine. They will also work with the World Health Organization on vaccine prequalification to assess the vaccine for safety and efficacy. This should be completed quickly.
The Ebola vaccine has been a priority since the outbreak in West Africa from 2014-2016 where 28,000 people were infected and 11,000 died. The vaccine protects again the Zaire species of Ebola and was developed at Canada’s National Microbiology Laboratory led by Dr. Heinz Feldmann. Many researchers and health workers assisted with the process to get the Ebola vaccine approved, including designing the vaccine, conducting pre-clinical trials on animals, and working on the clinical trials for Merck’s application.
More than 250,000 people have been vaccinated in the DRC under “compassionate use.” The vaccine has been donated by Merck and will continue to be donated in the near future. Merck anticipates that the licensed vaccine will be available in the third quarter of 2020.
Read more from Stat news here.